A multicenter, non-randomized, open-label observational study to assess effectiveness of indacaterol as measured by patient reported outcomes in COPD patients in real life settings - INFLOW

ovartis Healthcare Private Limited0 个研究点目标入组 4,500 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Current diagnosis of moderate COPD (GOLD stage II) according to GOLD criteria 2009 (GOLD guidelines 2009)
•2. Patients starting treatment for the first time with a long-acting bronchodilator monotherapy (indacaterol monotherapy or any other LABA or LAMA monotherapy) according to local prescribing information (PI)/Summary of Product Characteristics (SmPC)
•3. Patients 40 years of age or older
•4. Smoking history of at least 10 pack-years
•5. COPD symptoms like cough, sputum secretion, wheezing
•6. Patients who agree to complete Clinical COPD Questionnaire (CCQ)
•7. Patients who provide written informed consent to have their data collected and used for the purpose of this study. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care

•1.Previous diagnosis of asthma
•2.Contraindications mentioned in the local PI/SmPC for the prescribed study drug
•3.History of cancer, concomitant pulmonary disease, prolonged QT syndrome, or alpha-1-anti-trypsin deficiency
•4.Pregnant or lactating women
•5.Patients in acute exacerbation (requiring antibiotics or hospitalization) at study entry
•6.Patients with acute/active cardiovascular disease at study entry
•7.Unwillingness or inability to comply with the study requirements
•8.Patients on inhaled corticosteroids (ICS) therapy at study entry or during the 3 months prior to the study entry
•9.Patients using 2 different LABAs, LABA+LAMA, LABA+ICS combination or triple therapy (LAMA+LABA+ICS)
•10.Patients on maintenance therapy with SABA and/or SAMA

发起方

ovartis Healthcare Private Limited